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vildagliptinEmail Help AboutAuthorisation detailsProduct informationAssessment historyAbout
This is a summary of the European public assessment report (EPAR) for Galvus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Galvus.
What is Galvus?Galvus is a medicine that contains the active substance vildagliptin. It is available as round, yellow tablets (50 mg).
What is Galvus used for?Galvus is used to treat type 2 diabetes mellitus. It is used together with another antidiabetes medicine (as ‘dual therapy’) when the patient’s diabetes is insufficiently controlled by this other medicine taken alone. Galvus can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
The medicine can only be obtained with a prescription.

rcp galvus


The medicine can only be obtained with a prescription.
How is Galvus used?In adults, the recommended dose of Galvus is:
one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione;one tablet in the morning when taken with a sulphonylurea. The daily dose should not exceed two tablets (100 mg).
Galvus is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease. Galvus is not recommended for patients with liver problems.
How does Galvus work?Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
How has Galvus been studied?Galvus has been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.

Three of these studies looked at the effects of Galvus taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it with placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).

The other four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
What benefit has Galvus shown during the studies?Galvus reduced levels of HbA1c in all studies. When used alone, it caused a reduction in HbA1c levels by approximately 1 percentage point from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.

When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels. With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0. 8 and 1. 0 percentage points. In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0. 6 percentage points. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0. 3 to a rise of 0. 2 percentage points.

Although adding Galvus to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.

rcp galvus

The company withdrew its application for the use of Galvus on its own and as an add-on to insulin during the assessment of the medicine.
What is the risk associated with Galvus?The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Galvus, see the package leaflet.

Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients. Its use in patients with heart disease should be limited to patients with mild disease.

Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.
Why has Galvus been approved?The CHMP concluded that Galvus’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about GalvusThe European Commission granted a marketing authorisation valid throughout the European Union for Galvus to Novartis Europharm Limited on 19 November 2008. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Galvus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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rcp galvus


NameLanguageFirst publishedLast updated
Galvus : EPAR - Summary for the public Select a language to view the document Galvus : EPAR - Summary for the public
Galvus : EPAR - Summary for the public BG = balgarski ES = espanol CS = cestina DA = dansk DE = Deutsch ET = eesti keel EL = ellinika EN = English FR = francais IT = italiano LV = latviesu valoda LT = lietuviu kalba HU = magyar MT = Malti NL = Nederlands PL = polski PT = portugues RO = romana SK = slovencina SL = slovenscina FI = suomi SV = svenska 2008-03-10 2011-04-11

This EPAR was last updated on 11 04 2011 .
More detail is available in the Summary of Product Characteristics
Authorisation details
Product details
Product details for GalvusNameGalvus
EMA Product numberEMEA H C 000771
Active substancevildagliptin
INN or common namevildagliptin
Therapeutic areaDiabetes Mellitus, Type 2

ATC CodeA10BH02

Publication details
Publication details for GalvusMarketing Authorisation HolderNovartis Europharm Ltd.
Revision5
Date of issue of Market Authorisation valid throughout the European Union26 09 2007

Contact address:
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
Product information
Product information
24 01 2011 Galvus -EMEA H C 000771 -WS 0070
NameLanguageFirst publishedLast updated
Galvus : EPAR - Product Information Select a language to view the document Galvus : EPAR - Product Information
Galvus : EPAR - Product Information BG = balgarski ES = espanol CS = cestina DA = dansk DE = Deutsch ET = eesti keel EL = ellinika EN = English FR = francais IT = italiano LV = latviesu valoda LT = lietuviu kalba HU = magyar MT = Malti NL = Nederlands PL = polski PT = portugues RO = romana SK = slovencina SL = slovenscina FI = suomi SV = svenska IS = Islenska NO = Norsk 2009-09-17 2011-04-11


Contents
Annex I - Summary of product CharacteristicsAnnex IIA - Manufacturing Authorisation Holder responsible for Batch ReleaseAnnex IIB - Conditions of the Marketing AuthorisationAnnex IIIA - LabellingAnnex IIIB - Package LeafletPlease note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.

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Galvus : EPAR - All Authorised presentations Select a language to view the document Galvus : EPAR - All Authorised presentations
Galvus : EPAR - All Authorised presentations BG = balgarski ES = espanol CS = cestina DA = dansk DE = Deutsch ET = eesti keel EL = ellinika EN = English FR = francais IT = italiano LV = latviesu valoda LT = lietuviu kalba HU = magyar MT = Malti NL = Nederlands PL = polski PT = portugues RO = romana SK = slovencina SL = slovenscina FI = suomi SV = svenska 2008-03-10


Pharmaco-therapeutic Group
Drugs used in diabetes
Therapeutic Indication
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus:
As dual oral therapy in combination with
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin,
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.
Assessment History
Changes since initial authorisation of medicine
NameLanguageFirst publishedLast updated
Galvus : EPAR - Procedural steps taken and scientific information after authorisation (English only) 2009-09-17 2011-04-11

Initial Marketing authorisation documents
NameLanguageFirst publishedLast updated

rcp galvus

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